503B Compounding Pharmacy is an FDA-registered outsourcing facility operating under Section 503B of the Federal Food, Drug, and Cosmetic Act, providing large-scale, sterile compounded medications to healthcare systems across the United States. The pharmacy is built to serve hospitals, surgery centers, clinics, and licensed healthcare providers that require consistent, compliant, and scalable access to compounded pharmaceuticals without patient-specific prescriptions. Operating from its facility at 2160 W State Road 434, Longwood, FL 32779, 503B Compounding Pharmacy follows current Good Manufacturing Practice (cGMP) standards and is subject to routine FDA inspection. This places it in a fundamentally different category than traditional 503A pharmacies. The focus is not retail compounding or one-off prescriptions. The focus is controlled production, batch consistency, sterility assurance, and regulatory discipline. The facility specializes in sterile injectable and non-sterile compounded medications designed to address drug shortages, support procedural efficiency, and improve supply chain reliability for healthcare providers. All production is performed in ISO-classified cleanroom environments using validated processes, documented quality systems, and lot-level traceability. Each batch undergoes appropriate sterility, endotoxin, and potency testing based on risk level and formulation requirements. 503B Compounding Pharmacy prioritizes transparency and compliance over speed or marketing claims. Products are compounded using USP-grade ingredients sourced from vetted suppliers, with full documentation available for healthcare partners. Beyond production, the pharmacy supports client institutions with regulatory documentation, recall readiness, adverse event reporting protocols, and consistent supply planning. The company exists to solve real operational problems for healthcare organizations. Drug shortages, inconsistent manufacturers, and unreliable distributors create risk for patient care. A properly run 503B facility reduces that risk by acting as a compliant, predictable manufacturing partner rather than a reactive supplier.
503B Compounding Pharmacy operates as an FDA-registered outsourcing facility in strict compliance with Section 503B of the Federal Food, Drug, and Cosmetic Act. Our facility at 2160 W State Road 434, Longwood, FL 32779 is dedicated to the large-scale compounding of sterile and non-sterile medications. This designation signifies our commitment to the highest standards of quality, safety, and regulatory oversight, exceeding the requirements of a traditional compounding pharmacy. We provide these essential pharmaceutical compounds to healthcare practitioners and facilities, ensuring they have access to critical medications that are not otherwise commercially available.
The 503B outsourcing facility model is defined by its rigorous production standards. At our Longwood location, we adhere to Current Good Manufacturing Practices (cGMP), which are the same standards followed by major pharmaceutical manufacturers. This includes stringent environmental controls, extensive testing of components and finished products, and robust quality assurance protocols. Every batch of medication prepared at 503B Compounding Pharmacy is made under these exacting conditions, providing practitioners with a reliable and trusted source for patient-specific and office-use medications.
Our core service at 2160 W State Road 434, Longwood, FL 32779 is the preparation of office-use medications for healthcare providers. These are medications that a practitioner can keep on hand in their clinic or office to administer to patients as needed. This is distinct from patient-specific prescriptions. We compound a wide array of preparations, including sterile injectables, ophthalmics, topicals, and other dosage forms that are essential for various medical treatments and procedures. By serving as a dependable 503B outsourcing facility, we support the local medical community by alleviating drug shortage challenges and providing access to vital medications.
The team at 503B Compounding Pharmacy is comprised of highly skilled pharmacists, pharmacy technicians, and quality assurance professionals. Our staff is deeply knowledgeable in the science of compounding and the specific regulatory framework governing a 503B outsourcing facility. We are committed to operational excellence from our location at 2160 W State Road 434, ensuring every product that leaves our facility meets its labeled strength, purity, and quality. For healthcare providers seeking a partner in patient care, 503B Compounding Pharmacy represents a foundation of trust and pharmaceutical expertise.
To learn more about our services or to speak with our team, you can contact us via our website at or by calling us directly at (407)993-1381. 503B Compounding Pharmacy is located at 2160 W State Road 434, Longwood, FL 32779.
FAQ
What does it mean that you are a 503B outsourcing facility?
It means our pharmacy at 2160 W State Road 434, Longwood, FL 32779 is registered with the FDA and operates under Section 503B of the FD&C Act. We comply with Current Good Manufacturing Practices (cGMP) for large-scale compounding, which involves more rigorous quality and safety standards than a traditional compounding pharmacy.
Who can order medications from 503B Compounding Pharmacy?
Our services at 2160 W State Road 434, Longwood, FL 32779 are designed for healthcare practitioners and facilities. We provide office-use medications for physicians, clinics, hospitals, and other healthcare providers to have on hand for patient care.
Do you fill prescriptions for individual patients at your Longwood location?
No. As a 503B outsourcing facility, our primary function is the large-scale production of medications for office-use by healthcare providers. We do not typically compound medications based on individual patient prescriptions from that location.
What kinds of medications do you compound at your facility?
At our location on W State Road 434, we compound a wide range of sterile and non-sterile preparations. This includes, but is not limited to, sterile injectables, ophthalmics, and topical formulations that are often needed by healthcare providers for procedures and treatments.
How can a healthcare provider place an order with your pharmacy?
Healthcare providers interested in our services can initiate the process by contacting our team directly. You can reach us at (407)993-1381 to discuss your needs and our ordering procedures. Our facility is located at 2160 W State Road 434, Longwood, FL 32779.